A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of NEUK203-215 Injection in Adult Chinese Patients With Relapsed/Refractory Autoimmune Diseases

Recruiting Early Phase 1 Interventional Study
Autoimmune
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
8 (estimated)
Sponsor
Neukio Biotherapeutics (Shanghai) Co., Ltd. · Industry
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About This Trial
The purpose of this study is to determine the safety, tolerability and preliminary efficacy of NEUK203-215 , a healthy donor (HD) allogeneic CD19/BCMA-targeted CAR-NK cell product, in participants with severe, refractory autoimmune diseases. This study plans to conduct an interim data analysis when the cumulative enrollment reaches 50% of the total sample size. The objectives of this analysis are…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 1\) Has provided signed informed consent; 2) Is aged 18-65 years ; 3)Adequate functional reserve of vital organs 4) Has a confirmed diagnosis of systemic lupus erythematosus, diffuse systemic sclerosis, inflammatory myopathy, or autoimmune bullous dermatosis. Exclusion Criter…
Contacts

Huji Xu

+86 21 8188 5514

xuhuji@smmu.edu.cn

CONTACT